Manager, Medical Device Labeling and Operations

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, Liva Nova is where your talent can truly thrive.

Join our talented team members worldwide to become a pioneer of tomorrow—because at Liva Nova,
we don’t just treat conditions — we aspire to alter the course of lives.

The Regulatory Labeling & Operations Manager is responsible for the development, implementation, and oversight of global product labeling strategy and operations for Neuromodulation therapies. This role is critical in ensuring our products are safely and effective for use, while meeting regulatory requirements. The position requires a strong knowledge of medical device regulations, excellent writing and communication skills, and experience in labeling development, localization, and vendor management.

The position partners closely with Regulatory Affairs, Quality, R&D, Clinical, Marketing and Operations to support sustaining product development, global submissions, and post-market activities.

This role leads and oversees end-to-end ownership of labeling activities, including sustaining labeling, compliance, UDI management, e-labeling, and localization. The role ensures all labeling (IFU, packaging labels, e-labeling, and software UI text) is accurate, compliant, and aligned with global regulatory requirements, while also driving scalable processes across UDI, localization, and labeling operations.

• Own end-to-end labeling activities for Neuromodulation product portfolios, including updates, remediation, and lifecycle maintenance

• Lead EU MDR labeling activities, including gap assessments, remediation plans, and implementation

• Define and maintain global labeling strategies aligned with FDA, EU MDR, and international regulatory requirements

• Lead global translation and localization processes, including vendor management and oversight

• Support internal and external audits (FDA, Notified Body, MDSAP)

• Develop, review, and maintain product labeling documentation, including:

• Physician and Patient Instructions for Use (IFUs)

• Package labeling and implant cards

• Software UI text and labeling content

• Ensure labeling aligns with product requirements, intended use, and regulatory standards
• Manage labeling review, approval, and release processes, ensuring accuracy and compliance

• Own and maintain UDI strategy and implementation across all therapies, including:
• DI/GTIN assignment and lifecycle management
• Compliance with FDA, EU MDR, and global UDI requirements
• Coordinate with Operations, IT, and Supply Chain to ensure successful labeling implementation
• Ensure labeling readiness within DMR, ERP, and document control systems

• Define and oversee labeling verification and validation activities
• Ensure traceability between labeling content and system/product requirements
• Collaborate with QA and verification teams to ensure labeling accuracy and completeness
• Ensure labeling activities are fully integrated within design control and change management processes

• Own and manage e-labeling platforms and website content
• Ensure compliance with global electronic labeling requirements
• Maintain version control and availability of approved labeling content
• Lead multi-channel labeling strategies (print and digital delivery)

• 8+ years of…